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NCT01601067 · ClinicalTrials.gov registry record · Phase 2
Integrated Alcohol Disorder and PTSD Treatment
A Phase 2 study of PTSD and Alcoholism, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
- 1
- Study location
NCT01601067: Completed Phase 2 study of PTSD and Alcoholism, sponsored by VA Office of Research and Development.
NCT01601067 is a Phase 2 study of PTSD and Alcoholism that has completed, run by VA Office of Research and Development. The registered enrollment target is 168 participants, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01601067, a Phase 2 study of PTSD and Alcoholism, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
- 1
- Study location
Study Summary
Comorbidity of alcohol use disorder (AD) and posttraumatic stress disorder (PTSD) is common. Currently available treatments often do not lead to sustained recovery from these disorders, possibly because they typically do not include exposure therapy which is considered best practice treatments for PTSD. This study compares exposure-based integrated treatment to integrated coping skills psychotherapy (a well disseminated practice) for comorbid AD and PTSD with the hypothesis that exposure therapy will allow those with PTSD to better sustain PTSD symptom reduction and reduction in alcohol use. The aim of this grant is to change common treatment practices for comorbid AD and PTSD by increasing the availability of evidence-based PTSD treatment for those with AD.
Primary Outcome
The CAPS-5 (score range, 0-80, with 0 indicating no PTSD symptoms and 80 indicating extreme ratings across all symptoms), a 30-item structured interview considered to be the criterion standard for PTSD, was the primary measure of PTSD symptoms and diagnosis. Diagnosis was determined using the rule of a severity score of 2 or higher, which follows DSM-5 PTSD criteria.
Conditions Studied
Interventions
- BEHAVIORAL Seeking Safety
- BEHAVIORAL Integrated Prolonged Exposure Therapy
Study Locations (1)
California
- VA San Diego Healthcare System, San Diego, CA - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2013-01-21 |
| Est. Completion | 2018-03-30 |
| Phase | Phase 2 |
What the finished NCT01601067 record still lists
NCT01601067 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (44% lower).
The record links to 2 conditions, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which Seeking Safety is the first listed.
NCT01601067 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01601067 about?
NCT01601067 is a clinical study titled "Integrated Alcohol Disorder and PTSD Treatment". Comorbidity of alcohol use disorder (AD) and posttraumatic stress disorder (PTSD) is common. Currently available treatments often do not lead to sustained recovery from these disorders, possibly because they typically do not include exposure therapy which is considered best practice treatments for P...
What is the current status of trial NCT01601067?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2013-01-21. Estimated completion is 2018-03-30.
What conditions does trial NCT01601067 study?
This clinical trial studies the following conditions: PTSD, Alcoholism.
What interventions are being tested in trial NCT01601067?
The interventions under investigation include: Seeking Safety (BEHAVIORAL), Integrated Prolonged Exposure Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01601067?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01601067 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for PTSD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01601067's enrollment target sits among peer trials
168 37th of 154 higher than 116 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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